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China has pledged to stem a flood of the synthetic opioid fentanyl onto America’s streets...security experts are skeptical about whether Beijing is willing, or even able, to follow through... Beijing appears to have offered its help so that it could get the best deal possible from Washington in trade negotiations...In April, China pledged...it would expand the list of narcotics subject to state control to the more than 1,400 known fentanyl analogues...as well as any new ones developed in the future...The regulatory change is supposed to shut down the operations of illicit producers and traffickers who advertise and sell fentanyl products on video websites including Google’s YouTube and Vimeo, and on the Dark Web...They deliver the drugs to the U.S. market mainly in the mail, through express delivery services or trans-shipping them through Mexico and Canada...READ MORE

Federal prosecutors charged drug distributor Rochester Drug Cooperative and its former CEO with drug trafficking charges...the first criminal charges for a pharmaceutical company and executives in the nation's ongoing opioid crisis... This prosecution is the first of its kind: executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking...The U.S. Attorney's Office for the Southern District of New York charged Rochester Drug Cooperative...with "knowingly and intentionally" violating federal narcotics laws "by distributing dangerous, highly addictive opioids to pharmacy customers that it knew were being sold and used illicitly,"...RDC was also charged with failing to properly report thousands of suspicious orders of oxycodone, fentanyl and other controlled substances to the Drug Enforcement Agency...READ MORE

A physician ally of Purdue Pharma LP...has agreed to testify against the OxyContin maker and other drug companies, newly disclosed court records show...Dr. Russell Portenoy, a professor at the Albert Einstein College of Medicine, was an early advocate for the use of opioids for chronic pain...He also was named as a defendant in some of the lawsuits filed by cities, counties and states seeking to hold opioid makers - including Endo and Mallinckrodt Plc...But Portenoy...struck a deal with the plaintiffs to serve as a cooperating witness, the records show. In exchange for his dismissal from the suits, Portenoy provided the plaintiffs with documentation of opioid makers’ payments to him over the years, as well as a 36-page declaration that lays out what he would say on the witness stand...READ MORE

China will add fentanyl-related substances to a supplementary list of controlled narcotic drugs from May 1, the government said...The statement was jointly issued by the Ministry of Public Security, the National Health commission and National Medical Products Administration...U.S. Trade Representative Lighthizer said in March he would prefer to include China’s commitments to curb fentanyl in any trade agreement...READ MORE

In states where pharmacists were allowed to sell the potentially lifesaving opioid antidote naloxone without a prescription, fewer people died from opioid overdoses...The passage of laws that let pharmacists sell naloxone directly to patients was associated with a nearly 30 percent drop in the number of opioid overdose deaths compared to states without pharmacist dispensing, researchers report in JAMA Internal Medicine...When the researchers examined the laws involving naloxone prescriptions, they found that few states had any form of legislation before 2010. By 2016, 47 states had passed some sort of law regarding the life-saving medication, but only nine had laws giving authority to pharmacists to sell naloxone directly to patients...READ MORE

The people charged across 11 federal districts, include 31 doctors, seven pharmacists, eight nurse practitioners, and seven other licensed medical professionals...The cases involve more than 350,000 prescriptions for controlled substances across Ohio, Kentucky, Tennessee, Alabama, and West Virginia...The Justice Department said six individuals, including two doctors and three registered pharmacists were charged with several counts, including unlawful distribution of controlled substances and conspiracy to obtain controlled substances by fraud...One arrest...involved a doctor in Kentucky who allegedly prescribed opioids to friends on Facebook, who would then come to his home to pick up prescriptions...Another case involved a doctor in Tennessee who branded himself the “Rock Doc.” He allegedly prescribed combinations of dangerous combinations of opioids and benzodiazepines, a class of psychoactive drugs, sometimes in exchange for sexual favors...READ MORE

SB262: Asthma drug pricing transparency

...Democratic Sen. Yvanna Cancela...has introduced a bill that would apply the same standards toward drugs that treat asthma...SB262 largely copies provisions of Cancela’s 2017 legislation on diabetes drug transparency, which requires the drug manufacturer to submit information to the state related to the cost of the pricing of the drug, and explain to the state whether the drug has undergone a substantial price increase in the past two years...SB262

SB378: Drug pricing board

Proposed by Democratic Sen. Yvanna Cancela, this measure would establish a statewide Prescription Drug Affordability Board, charged with identifying certain prescription drugs with pricing that creates challenges for insurers and patients and that would recommend an upper price and payment limit on the drug...The bill lays out the structure, make-up and abilities of the board, funded by taxes on prescription drug manufacturers based on their market share and the required costs of the board. It also lays out a process for setting upper recommendations on prescription drug prices, including requiring the suggested limits become mandatory after 2024...SB378

AB303: Regulation of kratom products

Sponsored by Assembly Republican Leader Jim Wheeler, this bill would require the state pharmacy board to regulate and oversee the sale of kratom, a Southeast Asian tropical tree with leaves that contain psychotropic effects...The bill would also prohibit the sale of kratom products to children under the age of 18, or to sell any kratom products that have been altered to become “injurious” to a consumer. It sets a $1,000 fine and separate civil penalty up to $1,000 for violations...AB303

AB239: Opioid clarification bill

...this bill would make changes to the opioid prescribing law passed in the 2017 legislative session that prompted complaints by physicians in the interim. The legislation would, among other things:
- Codify certain definitions from pharmacy board regulations, including course of treatment and acute pain
- Allow providers to still prescribe a controlled substance after reviewing a patient utilization report if they determine the prescription is medically necessary
- Allow providers to prescribe a longer initial prescription for a controlled substance for the treatment of acute pain than normally allowed by law if medically necessary
- Remove a requirement that a provider make a good faith effort to attempt to review a patient’s medical records before issuing an initial prescription of a controlled substance for the treatment of pain unless the initial prescription is for more than 30 days or the medical records are relevant to the prescription
- Repeal requirements that providers consider certain factors — including whether there is reason to believe the patient is not using drugs as prescribed, the number of attempts by a patient to obtain an early refill of a prescription and the number of times a patient claims a prescription has been lost or stolen — before prescribing a controlled substance...AB239

The founder of Insys Therapeutics Inc on Thursday became the highest-ranking pharmaceutical executive to be convicted in a case tied to the U.S. opioid crisis, when he and four colleagues were found guilty of participating in a scheme to bribe doctors to prescribe an addictive painkiller...A federal jury in Boston found John Kapoor, the drugmaker’s former chairman, and his co-defendants guilty of racketeering conspiracy for engaging in a scheme that also misled insurers into paying for the drug...READ MORE

Indivior Plc lost nearly three-quarters of its stock market value...and former parent Reckitt Benckiser also fell after the U.S. Justice Department accused the British drugmaker of illegally boosting prescriptions for its blockbuster opioid addiction treatment Suboxone...An indictment...alleged Indivior made billions of dollars by deceiving doctors and healthcare benefit programs into believing the film version of Suboxone was safer and less susceptible to abuse than similar drugs...The indictment charged Indivior and its subsidiary Indivior Inc with conspiracy, health care fraud, mail fraud and wire fraud. The U.S. government said it would seek to have it forfeit at least $3 billion...READ MORE

As Purdue Pharma grapples with thousands of lawsuits blaming the company for contributing to the opioid crisis, the drug maker has signaled it may file bankruptcy. If that happens, some newly created subsidiaries are likely to come under scrutiny...Purdue has launched two limited partnerships that are now marketing or developing drugs that were previously listed as part of the Purdue product portfolio. Several current and former Purdue executives run these companies, both of which the drug maker refers to as operating subsidiaries...The timing of all these activities — from creating the subsidiaries to transferring assets and employees — could be an issue for Purdue and the Sacklers, since these occurred not long before the drug maker indicated bankruptcy is a possibility...READ MORE